The present invention is directed to a textured bone allograft for implantation in a patient, having one or more textured bone surfaces, and methods of making and using the textured bone graft. The textured surface preferably includes a plurality of closely spaced discrete or continuous protrusions. The textured bone allograft is useful for repairing bone defects caused by congenital anomaly, disease, or trauma. The present textured bone allograft promotes the growth of patient bone at an implantation site by promoting osteoinductivity and cellularization, provides added stability and mechanical strength, and does not shift, extrude or rotate, after implantation.
In the field of bone grafts, small cut bone grafts and essentially intact bone grafts are implanted at a site in a patient. The success or failure of a bone graft depends on whether the bone graft remains at the implant site, is cellularized, and whether it can withstand the mechanical load. In spinal surgery, there are two primary indications for use of allograft bone: (1) when there is insufficient available autograft bone, and (2) in spinal fusion procedures when a structural element in needed. Typically, bone grafts are affixed at an implant site by fusion. Bone grafts for spinal applications often fail because they are extruded from the implantation site due to shifting, rotation, and slippage of the graft, are not cellularized, or fail mechanically. The present invention solves the problem of graft failure by providing a textured bone allograft which promotes the ingrowth of patient bone at an implantation site by promoting osteoinductivity and cellularization, provides added stability and mechanical strength, and does not shift, extrude or rotate, after implantation.
The present invention is directed to a textured bone allograft for repairing bone defects caused by congenital anomaly, disease, or trauma, including for example, for restoring vertical support of the anterior column. The present textured bone allografts can be used as structural allografts placed anteriorly in the spine as interbody grafts or as strut grafts spanning multiple segments. Posterior textured bone allografts can be used to supplement autologous bone for spinal fusions in patients who lack sufficient host bone and to avoid significant donor site morbidity. The present inventors have surprisingly discovered that providing a textured bone graft results in improved graft stability and osteoinductivity, without a decrease in mechanical strength.
The present invention is directed to a textured bone allograft having a plurality of closely spaced protrusions.
The present invention is directed to a textured bone allograft having a plurality of closely spaced protrusions where the protrusions are continuous, discrete, or a combination thereof.
The present invention is further directed to a textured bone allograft where the shape of the protrusions include: irregular; pyramidal; cuboidal; cylindrical; conical; and rectangular.
The present invention is directed to a textured bone allograft having a plurality of closely spaced protrusions where the cross-section of a continuous or discrete protrusion may be of any shape including for example: irregular; rectangular; square; oval; round; triangular; trapizoidal; and a regular or irregular curve; or any combination thereof.
The present invention is also directed to a textured bone allograft where the protrusions provided on one or more cut surfaces of the bone allograft are from 0.1 to 5.00 mm in height, preferably 0.3 to 3.0 mm in height, and most preferably 0.5 to 1.5 mm in height.
The present invention is directed to a textured bone allograft having a plurality of discrete protrusions on one or more cut surfaces where the protrusions are sized to be in the range of from about 0.5 to about 10.0 mm in length; 0.5 to about 10.0 mm in width and 0.1 to about 5.0 mm in height.
The present invention is directed to a textured bone allograft having a plurality of discrete protrusions on one or more cut surfaces where the protrusions are sized to be in the range of from about 1.5 to about 5.0 mm in length; 1.5 to about 5.0 mm in width and 0.5 to about 2.0 mm in height.
The present invention is directed to a textured bone allograft including textured fibular wedges; textured humeral wedges; textured femoral wedges; textured tibial wedges; textured fibular trapezoid wedges; textured humeral trapezoid wedges; textured femural trapezoid wedges; textured fibular shafts; textured humeral shafts; and textured femural shafts.
The present invention is also directed to a textured bone allograft having a plurality of protrusions where the protrusions are perpendicular to one or more cut surfaces of the allograft.
The present invention is directed to a textured bone allograft where the plurality of protrusions are located on at least one entire cut surface of the bone allograft.
The present invention is directed to a textured bone allograft where the plurality of protrusions are dimensioned to promote ingrowth of patient bone through increased surface area, at an implantation site.
The present invention is further directed to a textured bone allograft including a plurality of closely spaced protrusions provided on one or more surfaces of the bone allograft.
The present invention is directed to a textured bone allograft where the plurality of continuous protrusions include a plurality of protruding, continuous, concentric rings.
The present invention is further directed to a method of restoring vertical support of the anterior vertebral column by implanting the present textured bone allograft.
The present invention is also directed to a method of making a textured bone allograft by providing the bone allograft with a plurality of closely spaced protrusions on the allograft cut surfaces.
The present invention is further directed to a method for making a textured bone allograft by milling grooves into one or more cut surfaces of the bone allograft to form a plurality of closely spaced protrusions.